AlcoChange: A digital therapeutic for patients with alcohol-related liver disease.

Background & Aims: Maintenance of abstinence in alcohol-related liver disease (ARLD) is a major unmet therapeutic need. Digital therapeutics can deliver ongoing behavioural therapy, in real-time, for chronic conditions. The aim of this project was to develop and clinically test AlcoChange, a novel digital therapeutic for ARLD. Methods: AlcoChange was developed using validated behaviour change techniques and a digital alcohol breathalyser. This was an open-label, single-centre study. Patients with ARLD, ongoing alcohol use (within 1 month) and possession of a suitable smartphone were eligible. Patients were recruited from inpatient and outpatient settings, and received AlcoChange therapy for 3 months. The primary outcome was reduction in alcohol use from baseline to 3 months, measured by timeline follow-back. Secondary outcomes included: (i) compliance with the AlcoChange app, (ii) alcohol-related and all-cause hospital re-admissions up to 1 year, (iii) qualitative analysis to determine factors associated with compliance. Results: Sixty-five patients were recruited, of whom 41 completed the study per protocol. Patients compliant with the intervention (>60 logins over 3 months) had a significant reduction in alcohol use from baseline compared to non-compliant patients (median [IQR]: -100% [100% to -55.1%] vs. -57.1% [-95.3% to +32.13%], p = 0.029). The proportion attaining abstinence at 3 months was higher in the compliant group (57.1% vs. 22.2%, p = 0.025). The compliant group had a significantly decreased risk of subsequent alcohol-related re-admission up to 12 months (p = 0.008). Qualitative analysis demonstrated that receiving in-app feedback and the presence of a health-related 'sentinel event' were predictors of compliance with the intervention. Conclusions: Use of the novel digital therapeutic, AlcoChange, was associated with a significant reduction in alcohol use and an increase in the proportion of patients with ARLD attaining abstinence. Definitive randomised trials are warranted for this intervention. Impact and implications: Alcohol-related liver disease (ARLD) is an increasing health problem worldwide. The main cause of death and disability in ARLD is ongoing alcohol consumption, but few patients receive medications or talking therapy to maintain abstinence. This study demonstrated that a digital therapeutic, linked to a smartphone, may help reduce alcohol consumption and alcohol-related hospital admissions in these patients. If validated in larger, randomised, trials, digital therapeutics may have a role in the primary and secondary prevention of complicatons from ARLD.

Improving access to general practice for people with severe and multiple disadvantage: a realist review protocol (The Connection Study).

Introduction: Despite having high unmet health need, people with severe and multiple disadvantage (SMD, including combinations of homelessness, substance misuse, poor mental health and domestic violence and abuse) have poor access to general practice. This realist review will examine the existing evidence on interventions or aspects of routine care in general practice that are likely to increase or decrease access to general practice for people with SMD. Methods and analysis: he aim of this review is to identify how these interventions or aspects of routine care increase or decrease access to general practice for people with SMD, in which contexts and for which patients. This review will involve a process comprising five sequential phases: (1) identifying established theories, (2) conducting an extensive search for proof, (3) selecting appropriate articles, (4) gathering and organising relevant data, and (5) utilising a realist analytical approach to synthesise evidence and make conclusions. Local implementation documents, in addition to published research studies, will be incorporated to enrich the analysis. We will collaborate with a stakeholder group consisting of people with lived experience of SMD and those who support them to advise us throughout. Ethics and dissemination: Ethical approval is not required. Our findings will be disseminated through peer-reviewed publications, conference presentations and lay summaries and will be used to develop a complex intervention for improving access to general practice for and with people with severe and multiple disadvantage. PROSPERO registration number: CRD42023390495.

Unintended consequences of patient online access to health records: a qualitative study in UK primary care.

BACKGROUND: Health systems are seeking to harness digital tools to promote patient autonomy and increase the efficiency of care worldwide. The NHS Long Term Plan created the right for patients to access 'digital first' primary care by 2023-2024, including online patient access to full medical records. AIM: To identify and understand the unintended consequences of online patient access to medical records. DESIGN AND SETTING: Qualitative interview study in 10 general practices in South West and North West England. METHOD: Semi-structured individual interviews with 13 patients and 16 general practice staff with experience of patient online access to health records. RESULTS: Online access generated unintended consequences that negatively impacted patients' understanding of their health care, with patients finding surprising or difficult to interpret information. Online access impacted GPs' documentation practices, such as when GPs pre-emptively attempted to minimise potential misunderstandings to aid patient understanding of their health care. In other cases, this negatively impacted the quality of the records and patient safety when GPs avoided documenting speculations or concerns. Contrary to assumptions that workload would be reduced, online access introduced extra work, such as managing and monitoring access, and taking measures to prevent possible harm to patients. CONCLUSION: The unintended consequences described by both staff and patients show that, to achieve the intended consequences set out in NHS policy, additional work is necessary to prepare records for sharing and to prepare patients about what to expect. It is crucial that practices are adequately supported and resourced to manage the unintended consequences of online access, now that it is the default position. A table of potential unintended consequences and mitigation measures is provided to aid practice managers and clinicians implementing online access.

PrEP use and unmet PrEP-need among men who have sex with men in London prior to the implementation of a national PrEP programme, a cross-sectional study from June to August 2019.

BACKGROUND: Access to prevention options, including HIV pre-exposure prophylaxis (PrEP), remains a public health priority for gay, bisexual, and other men who have sex with men (MSM), especially in London. We describe PrEP use in a London community sample of MSM before the introduction of a national PrEP programme in October 2020. METHODS: From June-August 2019, MSM aged ≥ 18 recruited from London commercial venues were asked to self-complete a sexual health questionnaire and provide an oral fluid sample for anonymous HIV antibody testing. Descriptive analyses of demographic characteristics, service engagement and outcomes, as well as sexual risk and prevention behaviours were examined in the survey population and in those reporting current PrEP use. We performed sequential, multivariate analyses examining current PrEP use in MSM of self-perceived HIV-negative/unknown status with identified PrEP-need defined as the report of condomless anal sex (CAS) in the last three months, or the report of CAS (in the last year) with an HIV-positive/unknown status partner not known to be on HIV treatment, in reflection of UK PrEP guidelines. RESULTS: One thousand five hundred and thirty-fifth questionnaires were completed across 34 venues, where 1408 were analysed. One in five MSM of self-perceived HIV-negative/unknown status reported current PrEP use (19.7%, 242/1230). In men with PrEP-need, 68.2% (431/632) did not report current use. Current PrEP use was associated with age (aOR: 3.52, 95% CI: 1.76-7.02 in men aged 40-44 vs men aged 18-25) and education (aOR: 1.72, 95% CI: 1.01-2.92 in men with ≥ 2 years/still full-time vs no/ < 2 years of education since age 16). CONCLUSION: Among MSM in London, PrEP use is high but there is indication of unmet PrEP-need in men of younger age and lower levels of post-16 education. National programme monitoring and evaluation will require continued community monitoring to guide interventions ensuring equitable PrEP access and uptake in those who could most benefit from PrEP.

Unintended consequences of online consultations: a qualitative study in UK primary care.

BACKGROUND: Health services are increasingly using digital tools to deliver care, and online consultations are being widely adopted in primary care settings. The intended consequences of online consultations are to increase patient access to care and increase the efficiency of care. AIM: To identify and understand the unintended consequences of online consultations in primary care. DESIGN AND SETTING: Qualitative interview study in eight general practices using online consultation tools in South West and North West England between February 2019 and January 2020. METHOD: Thematic analysis of semi-structured interviews with 19 patients and 18 general practice staff. RESULTS: Consequences of online consultations were identified that restricted patient access to care by making it difficult for some patients to communicate effectively with a GP and disadvantaging digitally-excluded patients. This stemmed from patient uncertainty about how their queries were dealt with, and whether practices used online consultations as their preferred method for patients to contact the practice. Consequences were identified that limited increases in practice efficiency by creating additional work, isolation, and dissatisfaction for some staff. CONCLUSION: Unintended consequences often present operational challenges that are foreseeable and partly preventable. However, these challenges must be recognised and solutions resourced sufficiently. Not everyone may benefit and local decisions will need to be made about trade-offs. Process changes tailored to local circumstances are critical to making effective use of online consultation tools. Unintended consequences also present clinical challenges that result from asynchronous communication. Online consultation tools favour simple, well-formulated information exchange that leads to diffuse relationships and a more transactional style of medicine.

The IHAT-GUT Iron Supplementation Trial in Rural Gambia: Barriers, Facilitators, and Benefits.

INTRODUCTION: In most sub-Saharan African countries iron deficiency anaemia remains highly prevalent in children and this has not changed in the last 25 years. Supplementation with iron hydroxide adipate tartrate (IHAT) was being investigated in anaemic children in a phase two clinical trial (termed IHAT-GUT), conducted at the Medical Research Council Unit the Gambia at the London School of Hygiene and Tropical Medicine (LSHTM) (abbreviated as MRCG hereof). This qualitative study aimed to explore the personal perceptions of the trial staff in relation to conducting a clinical trial in such settings in order to highlight the health system specific needs and strengths in the rural, resource-poor setting of the Upper River Region in the Gambia. METHODS: Individual interviews (n = 17) were conducted with local trial staff of the IHAT-GUT trial. Data were analysed using inductive thematic analysis. RESULTS: Potential barriers and facilitators to conducting this clinical trial were identified at the patient, staff, and trial management levels. Several challenges, such as the rural location and cultural context, were identified but noted as not being long-term inhibitors. Participants believed the facilitators and benefits outnumbered the barriers, and included the impact on education and healthcare, the ambitious and knowledgeable locally recruited staff, and the local partnership. CONCLUSIONS: While facilitators and barriers were identified to conducting this clinical trial in a rural, resource-poor setting, the overall impact was perceived as beneficial, and this study is a useful example of community involvement and partnership for further health improvement programs. To effectively implement a nutrition intervention, the local health systems and context must be carefully considered through qualitative research beforehand.

Equity considerations in outcome measures of the HIV pre-exposure prophylaxis care continuum in high-income countries: a systematic review protocol.

INTRODUCTION: HIV pre-exposure prophylaxis (PrEP) is an effective intervention to reduce acquisition of HIV. PrEP provision has increased in recent years, however, it is not known whether PrEP implementation has been equitably implemented across all risk groups, particularly groups experiencing high levels of health inequity. A PrEP care continuum (PCC) has been proposed to evaluate the success of PrEP implementation programmes, but the extent to which health equity characteristics are currently taken into account in the PCC has not been described. The objectives of this proposed systematic review are to (i) identify and collate outcome measure definitions for the main stages of the PCC (awareness, acceptability, uptake, adherence and retention), (ii) describe how equity characteristics are considered in outcome definitions of the PCC and (iii) describe data sources for capturing equity characteristics. METHODS AND ANALYSIS: Quantitative studies published between 1 January 2012 and 3 March 2020 will be included. Five databases (MEDLINE, PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Applied Social Sciences Index and Abstracts) will be searched to identify English language publications that include an outcome measure definition of at least one of the five main stages of the PCC. Risk of bias will be assessed using the Effective Public Health Practice Project Quality Assessment Tool for Quantitative Studies. Data on outcome measure definitions and equity characteristics will be extracted. Results will be presented in a narrative synthesis and all findings will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. ETHICS AND DISSEMINATION: Ethical approval is not required. The results will be disseminated via submission for publication to a peer-reviewed journal when complete. The review findings will have relevance to healthcare professionals, policymakers and commissioners in informing how to best evaluate PrEP implementation programmes and inform new implementation strategies for vulnerable and less advantaged populations. PROSPERO REGISTRATION NUMBER: CRD42020169779.

How does the sexual, physical and mental health of young adults not in education, employment or training (NEET) compare to workers and students?

BACKGROUND: Syndemic theory highlights the potential for health problems to interact synergistically, compounding impact. Young adults not in education, employment or training (NEET) are more likely to experience disadvantage and poorer general health outcomes. However, there is little research on their sexual health, or the extent to which this clusters with mental and physical health outcomes. METHODS: Analysis of data from 16 to 24 year olds (1729 men, 2140 women) interviewed 2010-12 for Britain's third National Survey of Sexual Attitudes and Lifestyles. Natsal-3 is a national probability sample survey using computer-assisted personal interviewing with computer-assisted self-interviewing. Participants were classified as workers, students or NEET. We used multivariable logistic regression to examine associations between being NEET (relative to worker or student) and risk behaviours and outcomes in physical, sexual and mental health domains. We then examined how risk behaviours and poor health outcomes cluster within and across domains. RESULTS: 15% men and 20% women were NEET; 36% men and 32% women were workers; and 49% men and 48% women were students. Young people who were NEET were more likely to report smoking and drug use (men) than other young people. There were few differences in sexual health, although NEETs were more likely to report condomless sex, and NEET women, unplanned pregnancy (past year). Risk behaviours clustered more within and across domains for NEET men. Among NEET women, poor health outcomes clustered across mental, physical and sexual health domains. CONCLUSIONS: Harmful health behaviours (men) and poor health outcomes (women) clustered more in those who are NEET. This points to a possible syndemic effect of NEET status on general ill health, especially for women. Our paper is novel in highlighting that elevated risk pertains to sexual as well as mental and physical health.

Accurately Assessing Gay Men's Erectile Functioning: A Critique of the International Index of Erectile Function (IIEF) Use with Gay Men.

The International Index of Erectile Functioning (IIEF) has been widely used to measure gay men's erectile functioning. However, the IIEF was initially developed using a sample of men whose sexual orientation was unspecified. Using scales not validated for specific populations can result in inaccurate assessments. The purpose of the current study was to evaluate the dimensionality, reliability, and validity of the IIEF with a large sample of gay men. One thousand and eighteen men self-identifying as "exclusively gay" completed an online survey consisting of demographics, the IIEF, the Hospital Anxiety and Depression Scale (HADS), the Perceived Stress Scale 4 (PSS4), and the Gay Male Sexual Difficulties (GMSD) erectile difficulties sub-scale. The replicability of the IIEF factor structure with a gay male sample was determined using exploratory and confirmatory factor analyses. Additionally, the HADS, PSS4, and GMSD were used to determine the validity of the IIEF. The current study was unable to replicate the IIEF factor structure. Four items required deletion and the factor solution differed from the original. Thus, reinterpretation of the latent variables was deemed necessary. Although the resultant 12-item IIEF evidenced model fit, validity, and reliability, it is not recommended for use with gay men. The revised IIEF is unable to accurately measure gay men's erectile functioning as the content of the items fail to capture their sexual behaviors (i.e., insertive and receptive anal sex).

How to increase chlamydia testing in primary care: a qualitative exploration with young people and application of a meta-theoretical model.

OBJECTIVE: The objective of this study was to explore young people's perspectives barriers to chlamydia testing in general practice and potential intervention functions and implementation strategies to overcome identified barriers, using a meta-theoretical framework (the Behaviour Change Wheel (BCW)). METHODS: Twenty-eight semistructured individual interviews were conducted with 16-24 year olds from across the UK. Purposive and convenience sampling methods were used (eg, youth organisations, charities, online platforms and chain-referrals). An inductive thematic analysis was first conducted, followed by thematic categorisation using the BCW. RESULTS: Participants identified several barriers to testing: conducting self-sampling inaccurately (physical capability); lack of information and awareness (psychological capability); testing not seen as a priority and perceived low risk (reflective motivation); embarrassment, fear and guilt (automatic motivation); the UK primary care context and location of toilets (physical opportunity) and stigma (social opportunity). Potential intervention functions raised by participants included education (eg, increase awareness of chlamydia); persuasion (eg, use of imagery/data to alter beliefs); environmental restructuring (eg, alternative sampling methods) and modelling (eg, credible sources such as celebrities). Potential implementation strategies and policy categories discussed were communication and marketing (eg, social media); service provision (eg, introduction of a young person's health-check) and guidelines (eg, standard questions for healthcare providers). CONCLUSIONS: The BCW provided a useful framework for conceptually exploring the wide range of barriers to testing identified and possible intervention functions and policy categories to overcome said barriers. While greater education and awareness and expanded opportunities for testing were considered important, this alone will not bring about dramatic increases in testing. A societal and structural shift towards the normalisation of chlamydia testing is needed, alongside approaches which recognise the heterogeneity of this population. To ensure optimal and inclusive healthcare, researchers, clinicians and policy makers alike must consider patient diversity and the wider health issues affecting all young people.

Male Body Image Self-Consciousness During Physical Intimacy (M-BISC): Validating the M-BISC With Gay Men.

INTRODUCTION: An expanding area of research within the realm of body image is its role in human sexual functioning, which denotes people's overall satisfaction with their performance during a specific sexual encounter. Traditionally, studies investigating the association between body image and sexual functioning have focused on women. The Male Body Image Self-Consciousness Scale (M-BISC) was developed to exclusively assess male body image self-consciousness during sexual activity using a sample consisting primarily of heterosexual men. AIM: The purpose of the current study is to evaluate the dimensionality, reliability, and validity of the M-BISC with a sample of gay men. Research suggests that sexual difficulties and body image concerns can overlap and interrelate. Therefore, 2 subscales (erectile difficulties and body embarrassment) from the Gay Male Sexual Difficulties Scale (GMSDS) were used to assess the validity of the scale. METHODS: 1,930 men self-identifying as "exclusively gay" completed an online survey consisting of demographics, the M-BISC, and the GMSDS (erectile difficulties and body embarrassment subscales). MAIN OUTCOME MEASURE: The replicability of the M-BISC factor structure with a gay male sample was determined using an exploratory and confirmatory factor analysis. Additionally, the GMSDS (erectile difficulties and body embarrassment subscales) was used to determine the validity of the M-BISC. RESULTS: Exploratory and confirmatory factor analyses revealed that, following the removal of 3 items, the M-BISC was unidimensional. Scale score reliability for the 14-item M-BISC was good. Finally, as predicted, scores on the M-BISC correlated with scores on the GMSDS (ie, greater sexual difficulties). CLINICAL IMPLICATIONS: The results indicate that assessment scales developed using samples consisting primarily of heterosexual men may not be appropriate for use with gay men in their original form. Thus, limiting the accuracy of the measurement and increasing the risk of misdiagnoses. STRENGTH & LIMITATIONS: Strengths of this study include a large sample of exclusively gay men and the utilization of best-practice statistical analysis for assessing factor structure, validity, and reliability of measures. Limitations include the assumption that the M-BISC should be used in lieu of a novel scale developed exclusively for gay men. Further, the study utilizes an Internet sample consisting primarily of Caucasian gay men. CONCLUSION: Results of the current study illustrate that the M-BISC is a valid tool to measure gay men's body concerns during intimacy. More importantly, it also highlights gay men's elevated body concerns during intimacy and the need to understand the etiology of these apprehensions. Currently, there is a noticeable gap in the literature regarding the cause of gay male body concerns that have potential clinic implications. Kiss MJ, Morrison TG, McDonagh LK. Male Body Image Self-Consciousness During Physical Intimacy (M-BISC): Validating the M-BISC With Gay Men. J Sex Med 2018;16:307-315.

Application of the COM-B model to barriers and facilitators to chlamydia testing in general practice for young people and primary care practitioners: a systematic review.

BACKGROUND: Chlamydia is a major public health concern, with high economic and social costs. In 2016, there were over 200,000 chlamydia diagnoses made in England. The highest prevalence rates are found among young people. Although annual testing for sexually active young people is recommended, many do not receive testing. General practice is one ideal setting for testing, yet attempts to increase testing in this setting have been disappointing. The Capability, Opportunity, and Motivation Model of Behaviour (COM-B model) may help improve understanding of the underpinnings of chlamydia testing. The aim of this systematic review was to (1) identify barriers and facilitators to chlamydia testing for young people and primary care practitioners in general practice and (2) map facilitators and barriers onto the COM-B model. METHODS: Qualitative, quantitative, and mixed methods studies published after 2000 were included. Seven databases were searched to identify peer-reviewed publications which examined barriers and facilitators to chlamydia testing in general practice. The quality of included studies was assessed using the Critical Appraisal Skills Programme. Data (i.e., participant quotations, theme descriptions, and survey results) regarding study design and key findings were extracted. The data was first analysed using thematic analysis, following this, the resultant factors were mapped onto the COM-B model components. All findings are reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. RESULTS: Four hundred eleven papers were identified; 39 met the inclusion criteria. Barriers and facilitators were identified at the patient (e.g., knowledge), provider (e.g., time constraints), and service level (e.g., practice nurses). Factors were categorised into the subcomponents of the model: physical capability (e.g., practice nurse involvement), psychological capability (e.g.: lack of knowledge), reflective motivation (e.g., beliefs regarding perceived risk), automatic motivation (e.g., embarrassment and shame), physical opportunity (e.g., time constraints), social opportunity (e.g., stigma). CONCLUSIONS: This systematic review provides a synthesis of the literature which acknowledges factors across multiple levels and components. The COM-B model provided the framework for understanding the complexity of chlamydia testing behaviour. While we cannot at this juncture state which component represents the most salient influence on chlamydia testing, across all three levels, multiple barriers and facilitators were identified relating psychological capability and physical and social opportunity. Implementation should focus on (1) normalisation, (2) communication, (3) infection-specific information, and (4) mode of testing. In order to increase chlamydia testing in general practice, a multifaceted theory- and evidence-based approach is needed. TRIAL REGISTRATION: PROSPERO CRD42016041786.

Internet-Based Interventions Aimed at Supporting Family Caregivers of People With Dementia: Systematic Review.

BACKGROUND: Caring for someone with dementia is one of the most challenging caring roles. The need for support for family caregivers has been recognized for some time but is often still lacking. With an aging population, demand on health and social care services is growing, and the population is increasingly looking to the internet for information and support. OBJECTIVE: In this review, we aimed to (1) identify the key components of existing internet-based interventions designed to support family caregivers of people with dementia, (2) develop an understanding of which components are most valued by caregivers, and (3) consider the evidence of effectiveness of internet-based interventions designed to support family caregivers of people with dementia. METHODS: We conducted a systematic search of online databases in April 2018. We searched reference lists and tracked citations. All study designs were included. We adopted a narrative synthesis approach with thematic analysis and tabulation as tools. RESULTS: We identified 2325 studies, of which we included 40. The interventions varied in the number and types of components, duration and dose, and outcomes used to measure effectiveness. The interventions focused on (1) contact with health or social care providers, (2) peer interaction, (3) provision of information, (4) decision support, and (5) psychological support. The overall quality of the studies was low, making interpretation and generalizability of the effectiveness findings difficult. However, most studies suggested that interventions may be beneficial to family caregiver well-being, including positive impacts on depression, anxiety, and burden. Particular benefit came from psychological support provided online, where several small randomized controlled trials suggested improvements in caregiver mental health. Provision of information online was most beneficial when tailored specifically for the individual and used as part of a multicomponent intervention. Peer support provided in online groups was appreciated by most participants and showed positive effects on stress. Finally, online contact with a professional was appreciated by caregivers, who valued easy access to personalized practical advice and emotional support, leading to a reduction in burden and strain. CONCLUSIONS: Although mixed, the results indicate a positive response for the use of internet-based interventions by caregivers. More high-quality studies are required to identify the effectiveness of internet interventions aimed at supporting family caregivers, with particular focus on meeting the needs of caregivers during the different stages of dementia.

Self-sampling kits to increase HIV testing among black Africans in the UK: the HAUS mixed-methods study.

BACKGROUND: Timely diagnosis of human immunodeficiency virus (HIV) enables access to antiretroviral treatment, which reduces mortality, morbidity and further transmission in people living with HIV. In the UK, late diagnosis among black African people persists. Novel methods to enhance HIV testing in this population are needed. OBJECTIVES: To develop a self-sampling kit (SSK) intervention to increase HIV testing among black Africans, using existing community and health-care settings (stage 1) and to assess the feasibility for a Phase III evaluation (stage 2). DESIGN: A two-stage, mixed-methods design. Stage 1 involved a systematic literature review, focus groups and interviews with key stakeholders and black Africans. Data obtained provided the theoretical base for intervention development and operationalisation. Stage 2 was a prospective, non-randomised study of a provider-initiated, HIV SSK distribution intervention targeted at black Africans. The intervention was assessed for cost-effectiveness. A process evaluation explored feasibility, acceptability and fidelity. SETTING: Twelve general practices and three community settings in London. MAIN OUTCOME MEASURE: HIV SSK return rate. RESULTS: Stage 1 - the systematic review revealed support for HIV SSKs, but with scant evidence on their use and clinical effectiveness among black Africans. Although the qualitative findings supported SSK distribution in settings already used by black Africans, concerns were raised about the complexity of the SSK and the acceptability of targeting. These findings were used to develop a theoretically informed intervention. Stage 2 - of the 349 eligible people approached, 125 (35.8%) agreed to participate. Data from 119 were included in the analysis; 54.5% (65/119) of those who took a kit returned a sample; 83.1% of tests returned were HIV negative; and 16.9% were not processed, because of insufficient samples. Process evaluation showed the time pressures of the research process to be a significant barrier to feasibility. Other major barriers were difficulties with the SSK itself and ethnic targeting in general practice settings. The convenience and privacy associated with the SSK were described as beneficial aspects, and those who used the kit mostly found the intervention to be acceptable. Research governance delays prevented implementation in Glasgow. LIMITATIONS: Owing to the study failing to recruit adequate numbers (the intended sample was 1200 participants), we were unable to evaluate the clinical effectiveness of SSKs in increasing HIV testing in black African people. No samples were reactive, so we were unable to assess pathways to confirmatory testing and linkage to care. CONCLUSIONS: Our findings indicate that, although aspects of the intervention were acceptable, ethnic targeting and the SSK itself were problematic, and scale-up of the intervention to a Phase III trial was not feasible. The preliminary economic model suggests that, for the acceptance rate and test return seen in the trial, the SSK is potentially a cost-effective way to identify new infections of HIV. FUTURE WORK: Sexual and public health services are increasingly utilising self-sampling technologies. However, alternative, user-friendly SSKs that meet user and provider preferences and UK regulatory requirements are needed, and additional research is required to understand clinical effectiveness and cost-effectiveness for black African communities. STUDY REGISTRATION: This study is registered as PROSPERO CRD42014010698 and Integrated Research Application System project identification 184223. FUNDING: The National Institute for Health Research Health Technology Assessment programme and the BHA for Equality in Health and Social Care.

"I Want to Feel Like a Full Man": Conceptualizing Gay, Bisexual, and Heterosexual Men's Sexual Difficulties.

Current understandings of sexual difficulties originate from a model that is based on the study of heterosexual men and women. Most research has focused on sexual difficulties experienced by heterosexual men incapable of engaging in vaginal penetration. To better understand men's perceptions and experiences of sexual difficulties, seven focus groups and 29 individual interviews were conducted with gay (n = 22), bisexual (n = 5), and heterosexual (n = 25) men. In addition, the extent to which difficulties reported by gay and bisexual men differ from heterosexual men was explored. Data were analyzed using thematic analysis applying an inductive approach. Two intercorrelated conceptualizations were identified: penis function (themes: medicalization, masculine identity, psychological consequences, coping mechanisms) and pain (themes: penile pain, pain during receptive anal sex). For the most part, gay, bisexual, and heterosexual men reported similar sexual difficulties; differences were evident regarding alternative masculinity, penis size competition, and pain during receptive anal sex. The results of this study demonstrate the complexity of men's sexual difficulties and the important role of sociocultural, interpersonal, and psychological factors. Limitations and suggested directions for future research are outlined.

Facilitators and barriers to chlamydia testing in general practice for young people using a theoretical model (COM-B): a systematic review protocol.

INTRODUCTION: Chlamydia is a key health concern with high economic and social costs. There were over 200 000 chlamydia diagnoses made in England in 2015. The burden of chlamydia is greatest among young people where the highest prevalence rates are found. Annual testing for sexually active young people is recommended; however, many of those at risk do not receive testing. General practice has been identified as an ideal setting for testing, yet efforts to increase testing in this setting have not been effective. One theoretical model which may provide insight into the underpinnings of chlamydia testing is the Capability, Opportunity and Motivation Model of Behaviour (COM-B model). The aim of this systematic review is to: (1) identify barriers and facilitators to chlamydia testing for young people in general practice and (2) use a theoretical model to conduct a behavioural analysis of chlamydia testing behaviour. METHODS AND ANALYSIS: Qualitative, quantitative and mixed methods studies published after 2000 will be included. Seven databases (MEDLINE, PubMed, EMBASE, Informit, PsycInfo, Scopus, Web of Science) will be searched to identify peer-reviewed publications which examined barriers and facilitators to chlamydia testing in general practice. Risk of bias will be assessed using the Critical Appraisal Skills Programme. Data regarding study design and key findings will be extracted. The data will be analysed using thematic analysis and the resultant factors will be mapped onto the COM-B model components. All findings will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. ETHICS AND DISSEMINATION: Ethical approval is not required. The results will be disseminated via submission for publication to a peer-review journal when complete and for presentation at national and international conferences. The review findings will be used to inform the development of interventions to facilitate effective and efficient chlamydia testing in general practice.

Development and Psychometric Evaluation of the Gay Male Sexual Difficulties Scale.

Sexual difficulties (i.e., disturbances in normal sexual responding) have the potential to significantly and negatively affect men's social and psychological well-being. However, a review of published measurement tools indicates that most have limited applicability to gay men, and none offer a nuanced understanding of sexual difficulties, as experienced by members of this population. To address this omission, the Gay Male Sexual Difficulties Scale (GMSDS) was developed using a sequential mixed-methods approach. The 25-item GMSDS uses a 6-point frequency Likert-type response format and examines: difficulties with receptive and insertive anal intercourse (5 items each); erectile difficulties (4 items); foreskin difficulties (4 items); body embarrassment (4 items); and seminal fluid concerns (3 items). The measure's scale score dimensionality, assessed using both exploratory and confirmatory factor analyses, as well as scale score reliability and validity (e.g., known-groups and convergent) was tested and deemed to be satisfactory. Limitations of the current series of studies and directions for future research are discussed.

A systematic review of sexual dysfunction measures for gay men: how do current measures measure up?

The measurement of subjective components of sexual functioning is of increasing importance in clinical research and practice. Differences have been reported in prevalence rates and experiences of sexual difficulties between heterosexual and gay men. The aim of this article is to identify reliable and valid measures of sexual dysfunction suitable for use with gay men. Seven measures were reviewed; details about item development, dimensionality, reliability, and validity are provided. Heteronormative and heterosexist wording were evident throughout. Several areas of concern emerged in relation to psychometric properties (e.g., questionable validity). No psychometrically robust sexual function measure was identified for use with gay populations.